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Item 4. Controls and Procedures

2026-05-11 compared with 2025-11-04 · 66 added, 50 removed, 111 unchanged (51% of the section changed)

14 unchanged sentences

LEG AL PROCEEDINGS

Except as discussed below, there are no material changes from the legal proceedings previously disclosed in our 2024 Annual Report during the three and nine months ended September 30, 2025.

On June 14, 2022, the Company received a paragraph IV notice of certification (the “Fresenius Kabi Notice”) from Fresenius Kabi advising that Fresenius Kabi had submitted an ANDA to the FDA seeking approval to manufacture, use or sell a generic version of CINVANTI in the U.S.

Except as discussed below, there are no material changes from the legal proceedings previously disclosed in our 2025 Annual Report during the three months ended March 31, 2026.

On June 14, 2022, the Company received a Paragraph IV notice of certification (the “Fresenius Kabi Notice”) from Fresenius Kabi advising that Fresenius Kabi had submitted an abbreviated new drug application (“ANDA”) to the U.S.

Food and Drug Administration (“FDA”) seeking approval to manufacture, use or sell a generic version of CINVANTI in the U.S.

prior to the expiration of U.S.

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9,561,229 and 9,974,794, which expire in 2035, are valid and would be infringed by Fresenius Kabi’s proposed generic product.

In view of the decision, the Court ordered that the effective date of any final approval by the U.S.

Food and Drug Administration of Fresenius Kabi’s ANDA shall not be a date earlier than September 18, 2035, the expiration date of each of U.S.

In view of the decision, the Court ordered that the effective date of any final approval by the FDA of Fresenius Kabi’s ANDA shall not be a date earlier than September 18, 2035, the expiration date of each of U.S.

9,561,229 and 9,974,794.

On January 8, 2025, Fresenius Kabi filed notice of appeal to the U.S.

Court of Appeals for the Federal Circuit (“Federal Circuit”).

Court of Appeals for the Federal Circuit.

On September 24, 2025, the briefing was completed, and the Company awaits a date for oral argument.

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On August 4, 2023, the Company received a Notice Letter (the “Mylan August Notice”) from Mylan Pharmaceuticals Inc.

(“Mylan”) advising that Mylan had submitted an abbreviated new drug application ("ANDA") to the FDA seeking approval to manufacture, use or sell a generic version of CINVANTI (“Mylan’s ANDA for a generic version of CINVANTI”) in the U.S.

prior to the expiration of U.S.

and 11,173,118 (the “CINVANTI Patents”), which are listed in the Orange Book.

The Mylan August Notice alleges that the CINVANTI Patents are invalid, unenforceable and/or will not be infringed by the commercial manufacture, use or sale of the generic product described in Mylan’s ANDA for a generic version of CINVANTI.

(“Mylan”) advising that Mylan had submitted an ANDA to the FDA seeking approval to manufacture, use or sell a generic version of CINVANTI (“Mylan’s ANDA for a generic version of CINVANTI”) in the U.S.

prior to the expiration of the CINVANTI Patents, which are listed in the Orange Book.

On September 15, 2023, the Company filed a complaint for patent infringement of the CINVANTI Patents against Mylan in the U.S.

District Court for the District of Delaware in response to the filing of Mylan’s ANDA for a generic version of CINVANTI.

The complaint seeks, among other relief, equitable relief enjoining Mylan from infringing the CINVANTI Patents.

On November 9, 2023, the Company received an updated Notice Letter from Mylan advising that it had submitted an amendment to Mylan’s ANDA for a generic version of CINVANTI to include a Paragraph IV certification to the Company's recently listed U.S.

On May 6, 2025, the Company announced that it entered into a settlement agreement with Mylan to resolve the ongoing patent litigation in the U.S.

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(“Mylan’s ANDA for a generic version of APONVIE”) prior to the expiration of U.S.

and 11,744,800 (the “APONVIE Patents”), which are listed

in the Orange Book.

The Mylan December Notice Letter alleges that the APONVIE Patents are invalid, unenforceable and/or will not be infringed by the commercial manufacture, use or sale of the generic product described in Mylan’s ANDA for a generic version of APONVIE.

and 11,744,800 (the “APONVIE Patents”), which are listed in the Orange Book.

On January 11, 2024, the Company filed a complaint for patent infringement of the APONVIE Patents against Mylan in the U.S.

District Court for the District of Delaware in response to Mylan filing an ANDA for a generic version of APONVIE.

The complaint seeks, among other relief, equitable relief enjoining Mylan from infringing the APONVIE Patents.

On January 26, 2024, the Court consolidated this litigation concerning Mylan’s ANDA for a generic version of APONVIE with the previously-filed litigation concerning Mylan’s ANDA for a generic version of CINVANTI.

District Court for the District of Delaware in response to Mylan filing its ANDA for a generic version of APONVIE.

On May 6, 2025, the Company announced that it entered into a settlement agreement with Mylan to resolve the ongoing patent litigation in the U.S.

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On December 11, 2023, the Company received a Paragraph IV notice of certification (the “Slayback Notice”) from Slayback Pharma LLC ("Slayback") (now owned by Azurity Pharmaceuticals, Inc.

("Azurity")) advising that Slayback had submitted an new drug application under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act to the FDA seeking approval to manufacture, use or sell a generic version of CINVANTI in the U.S.

(“Azurity”)) advising that Slayback had submitted a new drug application (“NDA”) under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act to the FDA seeking approval to manufacture, use or sell a generic version of CINVANTI in the U.S.

(“Slayback’s NDA”) prior to the expiration of the patents listed in the Orange Book.

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On December 12, 2024, the Company filed a complaint against Slayback, Azurity, and related entities in the U.S.

District Court for District of Delaware for patent infringement of the U.S.

District Court for District of Delaware for patent infringement of U.S.

12,115,254 and 12,115,255.

On May 23, 2025, the Company filed an amended complaint against Slayback, Azurity and related entities adding an allegation of patent infringement of U.S.

The parties completed expert discovery.

The parties’ entered into a stipulation (Case No.

On September 16, 2025, the parties entered into a stipulation (Case No.

24-1363, D.I.

119) limiting the issues for trial.

A bench trial is currently scheduled for November 17, 2025.

On November 17, 2025, the parties commenced a two-day bench trial centered on Azurity’s §112 defenses of claims from U.S.

12,115,255 and 12,290,520 that cover CINVANTI.

On February 6, 2026, the post-trial briefing was completed, and, on March 24, 2026, the Court held closing arguments.

The Company awaits the Court’s decision.

The Company intends to vigorously enforce its intellectual property rights relating to CINVANTI.

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(“Qilu”) advising that Qilu had submitted an ANDA to the FDA seeking approval to manufacture, use or sell a generic version of APONVIE in the U.S.

(“Qilu’s ANDA”) prior to the expiration of U.S.

11,744,800, 12,115,254, and 12,115,255 (the “Noticed APONVIE Patents”), which are listed in the Orange Book, Qilu's ANDA alleges that the Noticed APONVIE Patents are invalid, unenforceable and/or will not be infringed by the commercial manufacture, use or sale of the generic product described in Qilu’s ANDA for a generic version of APONVIE.

(“Qilu’s ANDA for a generic version of APONVIE”) prior to the expiration of U.S.

11,744,800, 11,878,074, 12,115,254, and 12,115,255 (the “Noticed APONVIE Patents”), which are listed in the Orange Book.

On March 21, 2025, the Company filed a complaint for patent infringement of the Noticed APONVIE Patents against Qilu in the U.S.

District Court for the District of Delaware in response to Qilu's ANDA for a generic version of APONVIE.

The complaint seeks, among other relief, equitable relief enjoining Qilu from infringing the Noticed APONVIE Patents.

On June 11, 2025, the Company received a Notice Letter (the “Qilu CINVANTI Notice”) from Qilu Pharmaceutical (Hainan) Co., Ltd and Qilu Pharma, Inc.

(“Qilu”) advising that Qilu had submitted an ANDA to the FDA seeking approval to manufacture, use or sell a generic version of CINVANTI in the U.S.

(“Qilu’s CINVANTI ANDA”) prior to the expiration of U.S.

On June 11, 2025, the Company received a Notice Letter (the “Qilu CINVANTI Notice”) from Qilu advising that Qilu had submitted an ANDA to the FDA seeking approval to manufacture, use or sell a generic version of CINVANTI in the U.S.

(“Qilu’s ANDA for a generic version of CINVANTI”) prior to the expiration of U.S.

and 12,290,520 (the “Noticed CINVANTI Patents”), which are listed in the Orange Book for CINVANTI.

Qilu’s CINVANTI ANDA alleges that the Noticed CINVANTI Patents are invalid, unenforceable, and/or will not be infringed by the commercial manufacture, use or sale of the generic product described in Qilu’s CINVANTI ANDA.

On July 3, 2025, the Company filed a complaint for patent infringement of the Noticed CINVANTI Patents against Qilu in the U.S.

District Court for the District of Delaware in response to Qilu’s CINVANTI ANDA.

The complaint seeks, among other relief, equitable relief enjoining Qilu from infringing the Noticed CINVANTI Patents.

District Court for the District of Delaware in response to Qilu’s ANDA for a generic version of CINVANTI.

On July 15, 2025, the Qilu CINVANTI and APONVIE litigations were consolidated.

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District Court for the District of Delaware related to Qilu’s ANDAs for generic versions of CINVANTI and APONVIE.

In connection with the settlement, on November 3, 2025, the parties filed a Stipulation and Order of Dismissal with the U.S.

In connection with the settlement, on November 6, 2025, the Court granted the Stipulation and Order of Dismissal with the U.S.

District Court for the District of Delaware requesting that the Court dismiss the pending litigation between the parties.

On November 19, 2025, the Company received a Paragraph IV notice of certification (the “Baxter Notice”) from Baxter Healthcare Corporation (“Baxter”) advising that Baxter had submitted an ANDA to the FDA seeking approval to manufacture, use or sell a generic version of CINVANTI (“Baxter’s ANDA for a generic version of CINVANTI”) in the U.S.

prior to the expiration of the Noticed CINVANTI Patents, which are listed in the Orange Book.

On December 23, 2025, the Company filed a complaint for patent infringement of the Noticed CINVANTI Patents against Baxter and a related entity in the U.S.

District Court for the District of Delaware in response to the filing of Baxter’s ANDA for a generic version of CINVANTI.

The Company entered into a settlement

agreement with Baxter to resolve the ongoing patent litigation in the U.S.

District Court for the District of Delaware related to Baxter’s ANDA for a generic version of CINVANTI.

In connection with the settlement, on April 28, 2026, the Court granted the Stipulation and Order of Dismissal with the U.S.

District Court for the District of Delaware requesting that the Court dismiss the pending litigation between the parties.

RIS K FACTORS

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We operate in a rapidly changing environment that involves a number of risks that could materially affect our business, financial condition or future results, some of which are beyond our control.

In addition to the other information described below, the risks and uncertainties that we believe are most important for you to consider are discussed in Part I, Item 1A.

"Risk Factors" in our 2024 Annual Report, Quarterly Reports on Form 10-Q, and other reports, including our financial statements and the related notes thereto, "Management's Discussion and Analysis of Financial Condition and Results of Operations" and the information contained in the section entitled "Forward-Looking Statements." The occurrence of any of the events or developments described below could adversely our business, financial condition, results of operations and prospects.

In such an event, the market price of our common stock could decline and you may lose all or part of your investment.

Additional risks and uncertainties not presently known to us or that we currently deem immaterial also may impair our business operations.

Other than the factors described below, there are no material changes to the risk factors described in the 2024 Annual Report.

The risks and uncertainties that we believe are most important for you to consider are discussed in Part I, Item 1A.

"Risk Factors" in our 2025 Annual Report, Quarterly Reports on Form 10-Q, and other reports, including our financial statements and the related notes thereto, "Management's Discussion and Analysis of Financial Condition and Results of Operations" and the information contained in the section entitled "Forward-Looking Statements." Additional risks and uncertainties not presently known to us or that we currently deem immaterial also may impair our business operations.

Changes in government policies, laws, and regulations and with respect to the government workforce may have a negative impact on our business and the markets in which we operate.

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Over the last several years, the U.S.

government has also shut down several times and certain regulatory agencies, such as the FDA and SEC, have had to furlough critical employees and stop critical activities.

government has also shut down several times and certain regulatory agencies, such as the FDA and SEC, have had to furlough employees, experience substantial funding cuts and pause or delay critical activities.

In addition, government funding of agencies on which our operations may rely, including those that fund research and development activities, is subject to the political process, which is inherently fluid and unpredictable, and spending allocations may undergo significant changes through congressional budgeting and appropriations processes.

Such disruptions at the FDA and other agencies may also increase the time necessary for new drugs or modifications to approved drugs to be reviewed and/or approved by necessary government agencies, which would adversely affect our business.

There is also a great degree of uncertainty related to the impact of recent U.S.

There is also a great degree of uncertainty related to the impact of U.S.

Supreme Court decisions and executive orders on the enforcement and decision-making authority of regulatory agencies, including those in the FDA, which may lead to delays, if not cancellations, of pending and proposed regulations at federal agencies and subject significant regulatory actions by the agencies to presidential supervision and control.

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trade policy, including potential new or increased tariffs, along with countermeasures by the affected countries, may impact global trade, create sourcing challenges with respect to raw materials and instruments and increase our costs, potentially harming our business.

has recently imposed increased tariffs on certain countries, focusing on those with which it has the largest trade deficits.

Other countries have responded, and may continue to respond, by announcing retaliatory tariffs on U.S.

The tariffs have disrupted and may continue to disrupt the global markets and escalate geopolitical tensions between

has imposed increased tariffs on certain countries and other countries have responded by announcing retaliatory tariffs on U.S.

The tariffs have disrupted and may continue to disrupt the global markets and escalate geopolitical tensions between the U.S.

and other countries.

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pharmaceutical companies from contracting with certain countries for the development, research or manufacturing of pharmaceutical products.

For example, the U.S.

Department of Commerce initiated national security investigations into the importation of pharmaceuticals and pharmaceutical ingredients pursuant to Section 232 of the Trade Expansion Act of 1962, which could result in the imposition of new tariffs on imports within the pharmaceutical industry.

For a discussion on the BIOSECURE Act and related risks, see "Risk Factors - Risks Related to Our Business - If we cannot maintain satisfactory pricing of our Products that is also acceptable to the U.S.

government, insurance companies, managed care organizations and other payors, or arrange for favorable reimbursement policies, our product sales may be adversely affected and our future revenue may suffer" in our Annual Report on Form 10-K for the year ended December 31, 2025.

In addition, the U.S.

announced a 100% tariff, effective October 1, 2025, on any branded or patented pharmaceuticals imported into the U.S., unless the relevant drug manufacturer has or is in the process of building a manufacturing facility in the U.S.

The imposition of such tariffs is currently delayed as the U.S.

administration seeks to negotiate drug pricing agreements with large drug manufacturers.

The outcome of such ongoing negotiations is currently unclear and the final terms and impact remain uncertain.

While we currently do not anticipate a material impact from such tariffs on our business or operations, such tariffs could have implications on drug pricing, drug production levels and patient access, and may result in supply chain or other operational disruptions.

Department of Commerce has initiated national security investigations into the importation of pharmaceuticals and pharmaceutical ingredients pursuant to Section 232 of the Trade Expansion Act of 1962, as amended (“Section 232”).

Further, the U.S.

announced a 100% tariff on any branded or patented pharmaceuticals imported into the U.S., from drug manufacturers that do not have, or are not in the process of building, a manufacturing facility in the U.S., which has been delayed as negotiations with large drug manufacturers continue.

Following the Section 232 investigations and other policy changes related to Most Favored Nation drug pricing, in April 2026, an executive order issued pursuant to Section 232, which seeks to impose up to a 100% tariff on imported patented pharmaceutics, subject to certain exceptions for certain products and for companies that have an agreement regarding Most Favored Nation drug pricing or onshore manufacturing.

Currently, the various tariffs that have been announced and enacted are not expected to have a material impact on the Company.

However, new tariffs or changes in the facts and circumstances impacting the Company could have a material impact to the Company.

The terms and effects of such tariffs, if and as they are implemented, and other policy changes are uncertain and could have adverse implications on drug pricing, drug production levels and patient access, and may result in supply chain or other operational disruptions.

Further, if we are required to change our current manufacturing partners or suppliers now or in the future in order to avoid such tariffs, the terms of new agreements that we may enter into may not be favorable to us and related operational disruptions may heighten manufacturing and compliance risks and derail commercialization plans.

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administration, or estimate the overall impact of any such changes on our business, results of operations and financial condition.

Provisions contained in our debt instruments may have a negative impact on our business.

Our Working Capital Facility Agreement contains customary representations and warranties and customary affirmative and negative covenants, including, among other things, restrictions on indebtedness, liens, investments, mergers, dispositions, prepayment of other indebtedness, and dividends and other distributions, subject to certain exceptions.

Our 2031 Convertible Notes also contain provisions that trigger events of default for incurring certain additional indebtedness or any default of our obligations under certain material agreements we may enter into.

As a result, we may not be able to raise funds through the issuance of additional debt in the future, which could impair our ability to finance our business obligations or pursue business expansion initiatives.

In addition, our Working Capital Facility Agreement contains a minimum cash covenant, a minimum revenue covenant and a minimum EBITDA covenant.

Our ability to comply with these restrictions and covenants, including meeting any financial ratios and tests, may be affected by events beyond our control.

We are in compliance with all covenants as of the period covered by this Quarterly Report on Form 10-Q.

We cannot provide any assurances that we will be able to maintain compliance with such restrictions and covenants in the future.

In the event of a default under the Working Capital Facility Agreement or any future debt agreement, our lenders could declare all outstanding principal, together with accrued and unpaid interest, to be immediately due and payable.

If the payment of the debt is accelerated, cash flows from our operations may be insufficient to repay such debt in full.

We may not be able to satisfy the continued listing requirements of Nasdaq to maintain a listing of our common stock.

As a company listed on The Nasdaq Capital Market, we must meet certain financial and liquidity criteria to maintain such listing.

If we violate Nasdaq’s maintenance requirements for the continued listing of our common stock, our common stock may be delisted.

For the 27 consecutive business days from March 10, 2026 through April 16, 2026, the closing bid price of our common stock did not meet the $1.00 per share minimum bid price required for continued listing on Nasdaq.

Pursuant to Nasdaq Listing Rule 5810(c)(3)(A), a failure to meet the continued listing requirement for minimum price shall be determined to exist if the deficiency continues for a period of 30 consecutive business days.

Upon receipt of notice from Nasdaq of such failure, a registrant has an initial 180-calendar day compliance period to regain compliance, and if a registrant is unable to regain compliance during this initial period, such registrant may be eligible for an additional 180-day compliance period, subject to meeting other continued listing standards and providing written notice to Nasdaq of its intent to cure the deficiency.

A registrant regains compliance by having a closing bid price of at least $1.00 per share of common stock for a minimum of 10 consecutive business days, unless Nasdaq exercises its discretion to extend this 10-day period pursuant to Nasdaq Listing Rule 5810(c)(3)(H).

Although we are currently in compliance with all continued listing requirements through the period covered by this Quarterly Report on Form 10-Q, we cannot provide any assurances that we will continue to satisfy these requirements in the future.

If our common stock is delisted, it may result in reduced liquidity of our common stock, limited availability of market quotations for our common stock, limited news and analyst coverage of our common stock, and a decreased ability to issue additional securities or raise capital through financing sources on terms that are acceptable to us, or at all.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 4. Controls and Procedures